Diagnostic Performance and Safety of a Novel Ferumoxytol-Enhanced Coronary Magnetic Resonance Angiography

Author:

Dong Zhou1,Si Guangxiang2,Zhu Xiaomei3ORCID,Li Chen1ORCID,Hua Rui1,Teng Jianzhen1,Zhang Wenhao1ORCID,Xu Lulu3,Qian Wen3,Liu Bo3,Wang Jun3,Wang Tong1,Tang Yingdan4ORCID,Zhao Yang4,Gong Xiaoxuan1,Tao Zhiwen1,Xu Zhihui1ORCID,Li Yong1,Chen Bo1,Kong Xiangqing1ORCID,Xu Yi3,Gu Ning15,Li Chunjian1ORCID

Affiliation:

1. Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China (Z.D., C.L., R.H., J.T., W.Z., T.W., X.G., Z.T., Z.X., Y.L., B.C., X.K., C.L.).

2. State Key Laboratory of Bioelectronics, Jiangsu Key Laboratory for Biomaterials and Devices, Southeast University, Nanjing, China (G.S., N.G.).

3. Department of Radiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China (X.Z., L.X., W.Q., B.L., J.W., Y.X.).

4. Department of Biostatistics, School of Public Health, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing, China (Y.T., Y.Z.).

5. Medical School, Nanjing University, Nanjing, Jiangsu, China (N.G.).

Abstract

BACKGROUND: Currently, noninvasive arteriography for the diagnosis of coronary artery disease is clinically limited to the computed tomography scanning, where patients have to be exposed to the radiation and risks associated with iodinated contrast. We aimed to investigate the diagnostic performance and safety of a novel ferumoxytol-enhanced coronary magnetic resonance angiography (CMRA) in patients with suspected coronary artery disease. METHODS: Thirty patients, 19 males, with a median age of 63 years old, and 17 with renal insufficiency, who were scheduled for invasive coronary angiography, were enrolled. Ferumoxytol was administered intravenously with a dose of 3 mg/kg during CMRA. Images were acquired with an ECG-triggered, navigator-gated, inversion recovery-prepared 3D fast low-angle shot sequence, and the image quality was assessed by a 4-point scale. Eighteen-segment coronary artery model was adopted to evaluate the visibility of the coronary arteries, and the image quality and stenosis were evaluated in nine segments. The diagnostic performance of CMRA is described as sensitivity, specificity, positive and negative predictive values, and accuracy with the invasive coronary angiography results as reference. The patients’ vital signs were monitored during CMRA, and their hepatic and renal functions were followed up for 3 months to evaluate the safety of ferumoxytol. RESULTS: Two hundred fifty-two of the 270 study segments were identified by CMRA, and their quality score reached 3.6±0.7. Referring to the invasive coronary angiography results, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ferumoxytol-enhanced CMRA reached 100.0%, 66.7%, 92.3%, 100.0%, and 93.3% respectively in patient-based analysis; 91.4%, 90.9%, 86.5%, 94.3%, and 91.1%, respectively in vessel-based analysis; and 92.3%, 96.7%, 83.7%, 98.6%, and 96.0%, respectively in segment-based analysis. No ferumoxytol-related adverse event was observed during the 3-month follow-up. CONCLUSIONS: Ferumoxytol-enhanced CMRA demonstrated good diagnostic performance and excellent safety in the diagnosis of significant coronary stenosis, providing an alternative to coronary computed tomography angiography for the diagnosis of coronary artery disease. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05032937.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging

Cited by 8 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3